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ContraBand™: Safety & Feasibility Study (RM-20-01)
Sponsor: Restore Medical Ltd
Summary
ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in a lower distal systolic pulmonary artery pressure (PAP) as well as an attenuation in the rise of the mean pulmonary capillary wedge pressure (PCWP) along with a higher pulmonary arterial compliance (PAC) distal to the constriction during exercise. Lower PCWP reflects the reduced left ventricular end diastolic pressure (LVEDP), contributing to enhanced ventricular filling and improved cardiac output. This hemodynamic change is anticipated to translate into enhanced physical capacity and a potentially more favorable prognosis for heart failure subjects. This study is an early feasibility, multi center, prospective, interventional, open-label, single-arm study.
Official title: ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2021-09-28
Completion Date
2032-12-31
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
ContraBand implants
Percutaneous implantation of the ContraBand devices by right heart catheterization
Locations (12)
Clinical Site
Aalst, Belgium
Clinical Site
Antwerp, Belgium
Clinical Site
Genk, Belgium
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Clinical Site
Lübeck, Germany
Clinical Site
Nahariya, Israel
Clinical Site
Petah Tikva, Israel
Kaplan Medical Center
Rehovot, Israel
Clinical Site
Klaipėda, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Clinical Site
Krakow, Poland
Clinical Site
Lublin, Poland